Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details

What are the generic sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride has three hundred and forty-nine patent family members in forty-eight countries.

Summary for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

International Patents:	349
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
DailyMed Link:	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Constraining patent/regulatory exclusivity:

9,616,028*PED

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
UnitedHealthcare	PHASE2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
Sabyasachi Sen	Phase 4

See all dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	8,628,799		Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y

Expired US Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	RE44186
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	6,414,126

International Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	020428
Poland	210304
Spain	2659862
Mexico	PA04011371	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO. (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD.)
Canada	2985797

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	C202030045	Spain		PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
2498758	CR 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
2498758	122020000018	Germany		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211	SPC/GB14/050	United Kingdom		PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1506211	588	Finland

Market Dynamics and Financial Trajectory for Dapagliflozin, Metformin Hydrochloride, and Saxagliptin Hydrochloride

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape for type 2 diabetes mellitus (T2DM) therapies is rapidly evolving. The drugs dapagliflozin, metformin hydrochloride, and saxagliptin hydrochloride occupy significant market positions owing to their efficacy, safety profiles, and approval status. Understanding their market dynamics and financial trajectories provides vital insights for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers.

Overview of the Drugs

• Dapagliflozin: An SGLT2 inhibitor marketed under brands like Farxiga (US) and Forxiga (Europe). Approved for T2DM, heart failure, and chronic kidney disease.
• Metformin Hydrochloride: The longstanding first-line oral agent for T2DM, known for its safety, efficacy, and cost-effectiveness.
• Saxagliptin Hydrochloride: A DPP-4 inhibitor marketed as Onglyza, used mainly for glycemic control with additional cardiovascular considerations.

Their differing mechanisms of action and therapeutic niches influence their respective market trajectories.

Market Dynamics

1. Market Size and Growth Potential

The global diabetes medication market is projected to reach approximately USD 50 billion by 2028, expanding at a compound annual growth rate (CAGR) of roughly 7% (Source: Fortune Business Insights).

• Metformin dominates the market due to its affordability and efficacy, constituting over 50% of oral antidiabetic prescriptions historically.
• Dapagliflozin and other SGLT2 inhibitors are witnessing rapid growth, driven by their cardiovascular and renal benefits beyond glycemic control, a trend supported by recent clinical trials.
• Saxagliptin has a steady but comparatively moderate market share, often serving as an add-on therapy after metformin.

2. Regulatory and Patent Landscape

• Dapagliflozin faces patent expirations in key markets over the next 5-7 years, prompting generic competition and pricing pressures. However, data exclusivity and formulations like fixed-dose combinations sustain its market share.
• Metformin is off-patent globally, with generics dominating the market, ensuring affordability but limiting profit margins for brand-name producers.
• Saxagliptin's patent protection is nearing expiration, leading to generic entry, although ongoing patent litigations and formulation patents occasionally delay generic proliferation.

3. Competitive Dynamics and Therapeutic Positioning

• Dapagliflozin competes with other SGLT2 inhibitors (empagliflozin, ertugliflozin) and GLP-1 receptor agonists, with differentiation centered on cardiovascular outcomes and renal benefits, bolstered by landmark trials such as DECLARE-TIMI 58.
• Metformin remains the cornerstone, with new formulations (immediate/extended-release) and combination therapies extending its market relevance.
• Saxagliptin faces competition from other DPP-4 inhibitors (sitagliptin, linagliptin) and emerging therapies with better tolerability or efficacy profiles.

4. Pricing and Reimbursement Policies

Pricing strategies significantly influence market dynamics.

• Metformin benefits from widespread reimbursement and low-cost generics.
• Dapagliflozin, being branded, commands premium pricing, though biosimilars may challenge this as patents expire.
• Saxagliptin's pricing is moderate but declining due to generic competition, especially outside North America.

Reimbursement policies variation across regions influences adoption rates, with payers favoring cost-effective options like metformin and biosimilars.

5. Prescriber and Patient Adoption

• Increasing awareness about cardioprotective benefits of SGLT2 inhibitors propels dapagliflozin's adoption, especially in patients with cardiovascular disease.
• The safety profile, including risks like genital infections from dapagliflozin, and concerns over pancreatitis with DPP-4 inhibitors like saxagliptin, influence prescribing habits.
• Patient preference favors oral agents with minimal side effects, bolstering demand for metformin and, increasingly, dapagliflozin.

Financial Trajectory Analysis

1. Revenue Trends

• Dapagliflozin has demonstrated robust sales growth, with revenues exceeding USD 3 billion globally in recent fiscal years, driven by expanding indications and geographic penetration.
• Metformin remains revenue-stable but faces stagnation margins due to patent expirations and generic competition; however, volume sales sustain profitability.
• Saxagliptin revenue has declined gradually owing to patent expirations and competitive pressures, with annual sales in the vicinity of USD 800 million.

2. Investment and R&D Outlook

Companies are investing heavily in expanding indications and developing combination therapies involving dapagliflozin and other antidiabetic agents to sustain growth. For example, dapagliflozin combinations with metformin and other novel agents constitute a significant R&D focus.
In contrast, R&D investments in saxagliptin have decreased, with strategic focus shifting to next-generation therapies or line extensions.

3. Impact of Patent Expirations

• Patent expiries, particularly for dapagliflozin and saxagliptin, threaten future revenues unless offset by biosimilars or new formulations.
• Launch of biosimilars is anticipated to compress prices, especially in regions like Europe and India.
• Companies are pursuing drug repositioning, such as exploring cardioprotective properties, to mitigate revenue erosion.

4. Market Penetration and Growth Strategies

• Strategic alliances, licensing agreements, and regional expansion play critical roles.
• Emphasizing clinical trial data to demonstrate cardiovascular and renal benefits reinforces market share, exemplified by dapagliflozin's inclusion in guidelines.
• Improving patient adherence through fixed-dose combinations and simplified dosing regimens is a continuing trend.

5. Future Market Outlook

• The combined effects of increased prevalence of T2DM, better insurance coverage, and growing physician acceptance of broader therapeutic benefits are expected to accelerate growth for dapagliflozin.
• Metformin's market will remain stable, with continued utilization driven by cost advantages and established safety profiles.
• Saxagliptin will see nuanced declines unless new indications or formulations rejuvenate its market relevance.

Key Market Drivers

• Clinical Evidence & Guidelines: Positive trial outcomes (e.g., FDA release on cardiovascular benefits for dapagliflozin) influence prescribing habits.
• Regulatory Approvals: Expanding indications, especially in heart failure and chronic kidney disease, open new revenue streams.
• Pricing & Reimbursement: Favorable policies propel market growth for cost-effective drugs like metformin while pressuring branded agents.
• Emerging Markets: Rapid urbanization and rising diabetes incidence in Asia-Pacific and Africa expand market opportunities.

Challenges & Limitations

• Patent cliff impacts revenue streams after patent expiration.
• Generic competition imposes pricing pressures.
• Safety concerns (e.g., infections, pancreatitis) influence prescribing behavior and market acceptance.
• Regulatory delays in approvals hamper timely market expansion.

Conclusion

The market for dapagliflozin, metformin hydrochloride, and saxagliptin hydrochloride is characterized by divergent dynamics—metformin's entrenched low-cost dominance versus dapagliflozin's innovative therapeutic profile and expanding indications. The future financial trajectory hinges on regulatory developments, patent landscapes, clinical evidence, and competitive strategies. Stakeholders must adapt to a landscape where innovation, pricing strategies, and regional policies increasingly determine market success.

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Key Takeaways

• Dapagliflozin's growth is driven by robust clinical data and expanded indications, positioning it as a lucrative asset despite patent expirations.
• Metformin will retain control over the market due to its affordability and longstanding clinical trust, but revenue growth may plateau.
• Saxagliptin faces ongoing patent expirations with limited upside unless new formulations or indications emerge.
• Strategic investments in R&D and regional market expansion are critical for future profitability.
• Regulatory and reimbursement policies are significant determinants; adaptive strategies are essential to navigate patent cliffs and generics influx.

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FAQs

1. What factors most influence the market growth of dapagliflozin?
Clinical trial outcomes demonstrating cardiovascular and renal benefits, expanding indications, patent protections, and regional approval status significantly influence dapagliflozin's growth trajectory.

2. How does patent expiration impact the revenues of these drugs?
Patent expirations typically lead to the introduction of generics or biosimilars, resulting in significant price reductions and moderating or diminishing revenues unless offset by new indications or formulations.

3. Why does metformin continue to dominate the diabetes medication market despite newer drugs?
Metformin’s low cost, proven safety, efficacy, and broad physician familiarity sustain its dominance, especially in regions with limited healthcare budgets or reimbursement constraints.

4. What are the primary challenges faced by saxagliptin?
Patent expiration leading to generic competition, safety concerns, and growing preference for other incretin-based therapies pose challenges to saxagliptin’s market share.

5. What strategies can companies adopt to maximize profitability in this competitive environment?
Investing in clinical research to support new indications, developing fixed-dose combination therapies, expanding into emerging markets, and navigating patent and regulatory landscapes effectively are key strategies.

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References

[1] Fortune Business Insights. "Global Diabetes Drugs Market Size, Share & Industry Analysis," 2022.
[2] U.S. Food & Drug Administration (FDA). "DECLARE-TIMI 58 Trial Results," 2019.
[3] MarketWatch. "Pharmaceuticals - Global Market Overview," 2022.
[4] IQVIA Data. "Global Diabetes Market Trends," 2022.